drugset / Trial / NCT03514537

Autologous Stem/Stromal Cellular Stromal Vascular Fraction (cSVF) In Frailty-Aging Processes

NCT03514537 ↗

Non-randomizedParallel-groupOpen-labelTreatment

Summary

With increasing age and health issues associated with aging, many systemic cellular and structural changes are known to occur. The intent of this trial is to determine the safety and efficacy of delivery of autologous cellular stromal vascular fraction (cSVF) to improve the quality of life and functional health. Isolation and concentration of cSVF will be documented. To acquire autologous cSVF, a 10+ teaspoon volume of subdermal adipose (fat) tissue and stroma is removed from the trunk or upper thigh area. Using a closed system with enzymatic digestion to isolate and concentrate these cells, is followed with returning these cSVF elements only via 500 cc Normal Saline delivered via peripheral vein (IV). Documentation of cellular numbers and flow cytometer viability testing is to be correlated with clinical outcomes as reported by patients and standardized Quality of Life (QoL) form tracking

Timeline

Start
2018-03-15
Primary completion
2027-03-15
Completion
2028-01-15

Outcome

Outcome not reported

Stopped: “COVID -19 closed facility and testing of subjects”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Background Liberase Protein / enzyme biologic — —